Table 2 Comparison of clinical and biochemical variables at baseline and at the end of the study in the different arms (per protocol analysis)

BMI (SDS)

2.32 ± 0.53

1.80 ± 0.36***

2.23 ± 0.57

1.99 ± 0.56*°

2.27 ± 0.74

2.18 ± 0.70°°°

Acanthosis nigricans, n (%)

7 (13.2)

3 (5.6)**

6 (13.3)

6 (13.3)

4 (11.4)

4 (11.4)

IGT

6 (11.3)

4 (7.5)

5 (11.1)

4 (8.8)

4 (11.4)

3 (8.6)

T2DM

2 (3.8)

1 (1.9)

1 (2.2)

1 (2.2)

-

-

Fasting glucose, mg/dL

90.62 ± 4.32

84.02 ± 4.23***

89.63 ± 3.17

86.72 ± 6.00^§§§°°°

90.90 ± 5.71

90.12 ± 2.89°°°

Fasting insulin, μU/mL

27.60 ± 7.83

18.04 ± 3.44***

26.71 ± 9.36

22.09 ± 3.67**°°°^§§§

27.39 ± 8.61

25.91 ± 4.41°°°

HbA1c, %, mmol/mol

5.63 ± 0.54

5.37 ± 0.35**

5.70 ± 0.52

5.40 ± 0.51*

5.68 ± 0.58

5.54 ± 0.50

HOMA-IR, mean (range)

5.69 (3.60–9.92)

3.38 (2.64–5.38)***

5.68 (2.00–10.90)

4.90 (3.15–6.26)*°°°^§§§

5.78 (4.21–8.89)

5.76 (4.00–6.19)°°°

IS_OGTT, SDS

1.40 ± 0.24

3.16 ± 0.83***

1.42 ± 0.22

1.74 ± 0.40***°°°

1.56 ± 0.48

1.43 ± 0.21°°°

Insulinogenic index, mean (range)

3.66 (1.90–9.25)

2.79 (1.84–8.27)*

2.54 (1.91–10.2)^##

2.40 (0.82–5.87)

3.12 (1.15–9.70)

2.95 (1.22–6.78)

Disposition index, mean (range)

4.42 (2.25–11.97)

10.28 (5.36–21.65)***

4.01 (0.83–11.72)

4.93 (1.53–7.27)*°°°

3.79 (1.88–9.28)

3.84 (1.69–5.82)°°°

Total cholesterol (mmol/L)

4.39 ± 0.51

3.31 ± 0.59***

4.36 ± 1.09

3.58 ± 0.93**

4.51 ± 0.79

3.74 ± 0.86**°

LDL cholesterol (mmol/L)

3.05 ± 0.60

2.87 ± 0.67

2.96 ± 0.73

2.92 ± 0.78

3.12 ± 0.81

2.99 ± 0.87

Triglycerides (mmol/L)

1.54 ± 0.40

1.63 ± 0.45

1.48 ± 0.29

1.61 ± 0.43

1.62 ± 0.51

1.54 ± 0.58